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Add to CartGlobal Oral Biologics & Biosimilars Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Therapy;
Lymphocyte Modulators, Interleukin Inhibitors, and Tumor Necrosis Factor-Alpha Inhibitors.By Disease;
Asthma, Crohn`S Disease, Carcinoma, Arthritis, Diabetes, Multiple Myeloma, Enterocolitis, Multiple Sclerosis, Sarcoma & Psoriasis, and Others.By Molecule Type;
Vaccines, Proteins & Peptides, Monoclonal Antibodies, and Other Molecule Types.By Distribution Channel;
Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Oral Biologics & Biosimilars Market (USD Million), 2021 - 2031
In the year 2024, the Global Oral Biologics & Biosimilars Market was valued at USD 7,678.52 million. The size of this market is expected to increase to USD 27,669.58 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 20.1%.
The global oral biologics and biosimilars market is experiencing significant growth, driven by advancements in biotechnology, increasing demand for targeted therapies, and efforts to improve patient access to biologic treatments. Biologics are complex molecules derived from living organisms, used to treat a wide range of diseases, including autoimmune disorders, cancer, and inflammatory conditions. While biologics have traditionally been administered via injections or infusions, the development of oral biologic therapies offers the potential for enhanced patient convenience, compliance, and quality of life. Oral biologics are designed to withstand degradation in the gastrointestinal tract and effectively deliver therapeutic agents to target sites within the body, providing an alternative to traditional routes of administration.
The rising prevalence of chronic diseases and the growing aging population are driving the demand for effective and affordable treatment options, creating opportunities for the expansion of the oral biologics and biosimilars market. Biosimilars are highly similar versions of approved biologic drugs, manufactured by different companies after the patent expiration of the originator product. Biosimilars offer cost savings compared to their reference biologics and play a crucial role in increasing access to biologic therapies, particularly in regions where healthcare budgets are constrained. The development and approval of oral biosimilars represent a significant milestone in the biopharmaceutical industry, as they provide additional options for patients and healthcare providers seeking alternative treatment modalities.
Regulatory initiatives aimed at streamlining the approval process for biosimilars and fostering competition in the biologics market are driving innovation and market growth. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established guidelines and pathways for the approval of biosimilars, creating a more conducive environment for the development and commercialization of oral biologic and biosimilar products. Additionally, collaborations between pharmaceutical companies, contract research organizations (CROs), and academic institutions are driving research and development efforts to overcome technical challenges associated with oral drug delivery and biosimilar development, further advancing the global oral biologics and biosimilars market.
Global Oral Biologics & Biosimilars Market Recent Developments
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In March 2022, Amneal Pharmaceuticals, Inc. announced that the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen, had been approved by the U.S. Food and Drug Administration (FDA). The product will be sold under the brand name RELEUKO.
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In December 2021, Gedeon Richter, Hungary's largest drug maker, reached an agreement with Hikma Pharmaceuticals, a London-listed drug maker, to out-license biosimilars denosumab for commercialization in the U.S.
Segment Analysis
The Global Oral Biologics & Biosimilars Market has seen significant growth across various segments, driven by advancements in biologic therapies and their increasing accessibility. By therapy, the market is segmented into Lymphocyte Modulators, Interleukin Inhibitors, and Tumor Necrosis Factor-Alpha Inhibitors. Lymphocyte modulators play a critical role in treating autoimmune diseases by regulating immune cell activity, while interleukin inhibitors are used in conditions like rheumatoid arthritis and psoriasis, helping to reduce inflammation. Tumor necrosis factor-alpha (TNF-α) inhibitors are pivotal in treating diseases like Crohn’s disease and arthritis, offering effective solutions for reducing inflammation and halting disease progression. These therapies are highly sought after due to their efficacy in managing chronic inflammatory conditions. By disease, the market encompasses a wide range of conditions including asthma, Crohn’s disease, carcinoma, arthritis, diabetes, multiple myeloma, enterocolitis, multiple sclerosis, sarcoma, psoriasis, and others. Biologics, including oral formulations, are increasingly used for managing asthma and psoriasis, with monoclonal antibodies and interleukin inhibitors leading the charge in treating autoimmune diseases like Crohn’s disease and multiple sclerosis. Oral biologics are revolutionizing cancer treatments, offering non-invasive options for conditions like carcinoma and multiple myeloma.
The market is also segmented by molecule type into vaccines, proteins & peptides, monoclonal antibodies, and other molecule types. Vaccines form a significant part of the biologics market, especially in preventing infectious diseases, while proteins and peptides are used in enzyme replacement therapies and hormonal treatments for various chronic conditions. Monoclonal antibodies are particularly dominant in the market, with their ability to target specific antigens making them effective in treating cancers and autoimmune disorders. The "other molecule types" category includes emerging therapies such as gene therapies and cell-based treatments, which are still in developmental stages but have the potential to expand the market further. By distribution channel, the market is divided into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies remain a primary channel for distributing biologics, especially for patients requiring inpatient care and specialized treatments. Retail pharmacies are essential for providing long-term treatments to chronic disease patients, while online pharmacies are growing in prominence, offering increased convenience and wider access to biologics, especially in remote regions. These diverse segments contribute to the rapid expansion of the global oral biologics and biosimilars market, offering more effective treatments and improving patient access worldwide.
Global Oral Biologics & Biosimilars Segment Analysis
In this report, the Global Oral Biologics & Biosimilars Market has been segmented by Therapy, Disease, Molecule Type, Distribution Channel and Geography.
Global Oral Biologics & Biosimilars Market, Segmentation by Therapy
The Global Oral Biologics & Biosimilars Market has been segmented by Therapy into Lymphocyte Modulators, Interleukin Inhibitors and Tumor Necrosis Factor-Alpha Inhibitors.
The global oral biologics and biosimilars market has been segmented by therapy into lymphocyte modulators, interleukin inhibitors, and tumor necrosis factor-alpha (TNF-α) inhibitors, reflecting the diverse range of biologic treatments available for various disease indications. Lymphocyte modulators target specific immune cells involved in autoimmune disorders, helping to regulate immune responses and reduce inflammation. These oral biologics are utilized in the treatment of conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, offering patients alternative treatment options to traditional systemic therapies.
Interleukin inhibitors represent another class of oral biologics that target cytokines involved in inflammatory pathways. By inhibiting the activity of interleukins, these medications help to mitigate inflammation and modulate immune responses, providing relief for patients with autoimmune and inflammatory conditions. Oral interleukin inhibitors are increasingly being developed and evaluated for their efficacy and safety in conditions such as psoriasis, asthma, and multiple sclerosis, offering potential benefits in terms of patient convenience and adherence compared to injectable formulations.
TNF-α inhibitors are a well-established class of biologic therapies that have revolutionized the treatment of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and inflammatory bowel disease. These oral biologics target TNF-α, a pro-inflammatory cytokine implicated in the pathogenesis of various inflammatory conditions. By blocking the action of TNF-α, these medications help to reduce inflammation and alleviate symptoms, improving patients' quality of life. The availability of oral TNF-α inhibitors provides patients with additional treatment options and may enhance treatment adherence, particularly for individuals who prefer oral medications over injectable formulations.
Global Oral Biologics & Biosimilars Market, Segmentation by Disease
The Global Oral Biologics & Biosimilars Market has been segmented by Disease into Asthma, Crohn`S Disease, Carcinoma, Arthritis, Diabetes, Multiple Myeloma, Enterocolitis, Multiple Sclerosis, Sarcoma and Psoriasis and Others.
The segmentation of the global oral biologics and biosimilars market by disease reflects the diverse therapeutic applications of these treatments across various medical conditions. In asthma management, oral biologics and biosimilars offer promising alternatives to traditional inhaler-based therapies, providing targeted relief and improved symptom control for patients with severe or uncontrolled asthma. Similarly, in Crohn's disease and enterocolitis, oral biologics play a crucial role in modulating the immune response and reducing inflammation in the gastrointestinal tract, offering patients a more convenient and effective treatment option compared to injectable biologics.
In oncology, oral biologics and biosimilars have emerged as transformative therapies for the treatment of carcinoma, sarcoma, and other malignancies. These agents target specific molecular pathways involved in cancer progression, leading to improved outcomes and reduced side effects compared to conventional chemotherapy. In diseases such as multiple myeloma and multiple sclerosis, oral biologics and biosimilars offer novel mechanisms of action for disease modification and symptom management, enhancing patient quality of life and long-term prognosis. Additionally, in chronic inflammatory conditions like arthritis, diabetes, and psoriasis, oral biologics provide targeted immunomodulatory effects, reducing disease activity and preventing long-term complications.
The segmentation of the oral biologics and biosimilars market by disease underscores the importance of personalized medicine and tailored treatment approaches based on the specific pathophysiology of each condition. Advances in biotechnology and drug delivery systems continue to drive innovation in oral biologics, enabling the development of more efficacious and patient-friendly therapies across a wide range of disease states. As research efforts and clinical trials expand our understanding of disease mechanisms and therapeutic targets, the global oral biologics and biosimilars market is poised for continued growth and differentiation, with opportunities for novel drug development and improved patient outcomes in diverse therapeutic areas.
Global Oral Biologics & Biosimilars Market, Segmentation by Molecule Type
The Global Oral Biologics & Biosimilars Market has been segmented by Molecule Type into Vaccines, Proteins & Peptides, Monoclonal Antibodies, and Other Molecule Types.
Vaccines, a key segment, are critical in preventing various infectious diseases and have gained significant importance in the biologics market due to their ability to stimulate immune responses in patients. Proteins and peptides also form a major part of the oral biologics market, as they have a variety of therapeutic applications, including hormone replacement therapy and enzyme replacements, offering effective treatments for several chronic conditions.
Monoclonal antibodies are another important category in this market, widely used in the treatment of cancers, autoimmune diseases, and other chronic conditions. These biologics work by targeting specific antigens, providing highly targeted and effective treatments. The "Other Molecule Types" category includes various other oral biologics and biosimilars, such as gene therapies and cell-based therapies, which are still under development or have niche applications. The increasing demand for these molecules reflects the growing role of biologics in treating complex diseases and the continuous evolution of new treatments within the biologics landscape.
Global Oral Biologics & Biosimilars Market, Segmentation by Distribution Channel
The Global Oral Biologics & Biosimilars Market has been segmented by Distribution Channel into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies.
Hospital pharmacies play a crucial role in distributing oral biologics and biosimilars to inpatients and outpatients, particularly for the treatment of complex conditions like cancer, autoimmune diseases, and chronic infections. These pharmacies ensure that patients receive the correct biologic therapy under medical supervision and provide vital support in monitoring for potential side effects or reactions. Given the specialized nature of many biologic treatments, hospital pharmacies are key in managing patient care and medication adherence.
Retail pharmacies serve as a widely accessible distribution channel for oral biologics and biosimilars, providing treatments to patients who need ongoing management for chronic conditions such as rheumatoid arthritis, diabetes, and multiple sclerosis. These pharmacies offer patients a convenient way to access their prescriptions and may provide counseling on proper medication use. Online pharmacies are gaining traction as an alternative distribution channel, offering the convenience of home delivery and catering to a broader patient base, including those in remote areas. The rise of e-commerce in healthcare has significantly expanded access to oral biologics and biosimilars, providing patients with more options for obtaining their medications from the comfort of their homes.
Global Oral Biologics & Biosimilars Market, Segmentation by Geography
In this report, the Global Oral Biologics & Biosimilars Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Oral Biologics & Biosimilars Market Share (%), by Geographical Region, 2024
In terms of geographical distribution, the global oral biologics and biosimilars market exhibits variation across different regions, with key factors influencing market share including regulatory frameworks, healthcare infrastructure, and patient access to innovative therapies. North America, comprising the United States and Canada, holds a significant share of the market due to a robust regulatory environment conducive to biosimilar development and adoption. The region benefits from established healthcare systems, high levels of healthcare expenditure, and a large patient population with chronic diseases, driving demand for oral biologics and biosimilars as cost-effective treatment options.
Europe is another major contributor to the global market share of oral biologics and biosimilars, with countries such as Germany, France, and the United Kingdom leading in terms of biosimilar approvals and utilization. The European Medicines Agency (EMA) has implemented regulatory pathways to facilitate the approval of biosimilars, resulting in widespread acceptance and adoption of these products across the region. Additionally, favorable pricing and reimbursement policies in certain European countries have incentivized the use of biosimilars, further contributing to their market penetration and uptake.
Asia Pacific, including countries such as Japan, China, and India, is witnessing rapid growth in the oral biologics and biosimilars market, driven by increasing healthcare expenditure, expanding access to innovative therapies, and a growing aging population. Governments in the region are implementing initiatives to promote the development and adoption of biosimilars as a means to address rising healthcare costs and improve access to biologic treatments. Furthermore, collaborations between multinational pharmaceutical companies and local manufacturers are driving biosimilar production and commercialization in Asia Pacific, contributing to the region's market share in the global oral biologics and biosimilars market.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Oral Biologics & Biosimilars Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Advancements in Biotechnology
- Increasing Demand for Targeted Therapies
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Efforts to Improve Patient Access to Biologic Treatments-Efforts to enhance patient access to biologic treatments are reshaping the global landscape of oral biologics and biosimilars market. Biologic therapies have revolutionized the treatment of various chronic diseases, offering targeted and often more effective treatment options compared to conventional pharmaceuticals. However, access to biologics has historically been limited due to factors such as high costs, complex manufacturing processes, and regulatory barriers. In response, healthcare stakeholders, including governments, insurers, and pharmaceutical companies, are implementing initiatives to improve affordability, availability, and accessibility of biologic treatments for patients worldwide.
One key strategy to improve patient access to biologic treatments is the development and commercialization of biosimilars, including oral formulations. Biosimilars are highly similar versions of approved biologic drugs, offering comparable efficacy, safety, and quality at a lower cost. By providing alternative treatment options to expensive originator biologics, biosimilars contribute to cost savings for healthcare systems and increase patient access to biologic therapies. Efforts to streamline the regulatory pathways for biosimilar approval and promote market competition have accelerated the adoption of biosimilars, driving market growth and expanding treatment options for patients with chronic diseases.
Patient assistance programs, reimbursement schemes, and pricing agreements are being implemented to address affordability barriers and improve patient access to biologic treatments, including oral formulations. Pharmaceutical companies are collaborating with healthcare providers, patient advocacy groups, and government agencies to develop innovative access programs that offer financial assistance, co-pay support, and patient education resources. Additionally, initiatives to enhance healthcare infrastructure, expand insurance coverage, and promote generic substitution policies contribute to improving patient access to biologic therapies globally. By addressing affordability and accessibility challenges, these efforts are paving the way for broader adoption of oral biologics and biosimilars, ultimately improving health outcomes and quality of life for patients with chronic diseases.
Restraints
- Technical Challenges in Oral Drug Delivery
- Regulatory Hurdles for Biosimilar Approval
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Competition from Originator Biologics-Competition from originator biologics poses a significant challenge to the global oral biologics and biosimilars market, particularly in terms of market penetration and adoption. Originator biologics, also known as reference products, are innovative therapies developed by pharmaceutical companies and protected by patents, granting them market exclusivity for a specified period. These originator biologics often have established efficacy, safety, and brand recognition, making them preferred treatment options for healthcare providers and patients. Consequently, biosimilar manufacturers face fierce competition from originator biologics when attempting to gain market share, especially in therapeutic areas with well-established biologic treatments.
Originator biologics may employ various strategies to maintain their market dominance and deter biosimilar competition. These strategies may include aggressive marketing campaigns, patent litigation, and pricing strategies such as discounts, rebates, and contracting arrangements with healthcare payers. Additionally, originator biologic manufacturers may invest in research and development efforts to extend patent protection through product improvements, reformulations, or new indications, further complicating biosimilar entry into the market. As a result, biosimilar manufacturers must navigate these competitive barriers and differentiate their products based on factors such as cost-effectiveness, accessibility, and patient outcomes to successfully compete with originator biologics.
Despite the challenges posed by competition from originator biologics, there are opportunities for biosimilar manufacturers to carve out a niche in the market and drive adoption of oral biologics and biosimilars. Regulatory initiatives aimed at increasing biosimilar approval pathways and fostering competition are creating a more favorable environment for biosimilar development and commercialization. Additionally, efforts to contain healthcare costs and improve patient access to biologic therapies are driving demand for cost-effective alternatives such as biosimilars, particularly in regions with limited healthcare budgets. With continued investment in research, development, and manufacturing capabilities, biosimilar manufacturers can capitalize on these opportunities to expand their market presence and offer patients more affordable and accessible treatment options.
Opportunities
- Expansion of Biosimilar Market
- Growing Aging Population
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Regulatory Initiatives for Streamlined Approval Processes-Regulatory initiatives aimed at streamlining the approval processes for oral biologics and biosimilars are driving innovation and market growth within the global pharmaceutical industry. Historically, the development and approval of biosimilars have faced significant regulatory hurdles due to the complexity of biologic molecules and the challenges associated with demonstrating similarity to reference products. However, regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have implemented pathways and guidelines to expedite the approval of biosimilars, encouraging competition and increasing access to affordable biologic therapies.
These regulatory initiatives include the establishment of rigorous scientific standards for demonstrating biosimilarity, as well as expedited review processes to facilitate the approval of biosimilar products. By providing clear guidance and requirements for biosimilar development and evaluation, regulatory agencies are fostering confidence in biosimilar products among healthcare professionals and patients, accelerating their adoption in clinical practice. Additionally, initiatives such as the FDA's Biosimilar Action Plan and the EMA's Biosimilar Medicines Regulatory Network aim to promote innovation and competition in the biosimilars market while ensuring patient safety and quality standards.
Regulatory agencies are actively engaging with stakeholders, including pharmaceutical companies, healthcare providers, and patient advocacy groups, to address challenges and identify opportunities for improvement in the regulatory framework for biosimilars. By fostering collaboration and dialogue, regulatory agencies can gather valuable insights into the needs and priorities of stakeholders, inform regulatory decision-making, and enhance the efficiency and effectiveness of biosimilar regulation. As a result, streamlined approval processes for oral biologics and biosimilars are expected to spur innovation, increase market competition, and ultimately improve patient access to affordable and high-quality biologic therapies globally.
Competitive Landscape Analysis
Key players in Global Oral Biologics & Biosimilars Market include:
- Novartis AG
- Amgen Inc.
- Pfizer Inc.
- Merck & Co., Inc.
- Teva Pharmaceutical Industries Ltd.
- Mylan N.V.
- Biocon Ltd.
- Sandoz International GmbH (a subsidiary of Novartis)
- Celltrion Inc.
- Biogen Inc.
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Therapy
- Market Snapshot, By Disease
- Market Snapshot, By Molecule Type
- Market Snapshot, By Distribution Channel
- Market Snapshot, By Region
- Global Oral Biologics & Biosimilars Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Advancements in Biotechnology
- Increasing Demand for Targeted Therapies
- Efforts to Improve Patient Access to Biologic Treatments
- Restraints
- Technical Challenges in Oral Drug Delivery
- Regulatory Hurdles for Biosimilar Approval
- Competition from Originator Biologics
- Opportunities
- Expansion of Biosimilar Market
- Growing Aging Population
- Regulatory Initiatives for Streamlined Approval Processes
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Oral Biologics & Biosimilars Market, By Therapy, 2021 - 2031 (USD Million)
- Lymphocyte Modulators
- Interleukin Inhibitors
- Tumor Necrosis Factor-Alpha Inhibitors
- Global Oral Biologics & Biosimilars Market, By Disease, 2021 - 2031 (USD Million)
- Asthma
- Crohn`S Disease
- Carcinoma
- Arthritis
- Diabetes
- Multiple Myeloma
- Enterocolitis
- Multiple Sclerosis
- Sarcoma
- Psoriasis and Others
- Global Oral Biologics & Biosimilars Market, By Molecule Type, 2021 - 2031 (USD Million)
- Vaccines
- Proteins & Peptides
- Monoclonal Antibodies
- Other Molecule Types
- Global Oral Biologics & Biosimilars Market, By Distribution Channel, 2021 - 2031 (USD Million)
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
- Global Oral Biologics & Biosimilars Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Oral Biologics & Biosimilars Market, By Therapy, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Novartis AG
- Amgen Inc.
- Pfizer Inc.
- Merck & Co., Inc.
- Teva Pharmaceutical Industries Ltd.
- Mylan N.V.
- Biocon Ltd.
- Sandoz International GmbH (a subsidiary of Novartis)
- Celltrion Inc.
- Biogen Inc.
- Company Profiles
- Analyst Views
- Future Outlook of the Market